Wescor, Inc Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
Brand
Wescor, Inc
Lot Codes / Batch Numbers
Lot Numbers: 6 units packages: 0256118, 0256131, 0256151, 0256195, 0256213, 0256248, 0256306, 0256354, 0257016, 0257113, 0257032, 0257071, 0257150, 100299, 100500, 100677, and 100183: Individual vials Lot Numbers: I-61-22, expiration 4/08 and I-62-34, expiration 10/08, Only individual vials of SS-025 (Lot I-62-34, expiration 10/08 ) included in Osmocoll SS-039 of 6 unit package Lot Numbers: 0397032 and 100455.
Products Sold
Lot Numbers: 6 units packages: 0256118, 0256131, 0256151, 0256195, 0256213, 0256248, 0256306, 0256354, 0257016, 0257113, 0257032, 0257071, 0257150, 100299, 100500, 100677, and 100183: Individual vials Lot Numbers: I-61-22 , expiration 4/08 and I-62-34, expiration 10/08; Only individual vials of SS-025 (Lot I-62-34, expiration 10/08 ) included in Osmocoll SS-039 of 6 unit package Lot Numbers: 0397032 and 100455.
Wescor, Inc is recalling Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufact due to Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
Recommended Action
Per FDA guidance
Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026